MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COMBUR 5-TEST HC 10 STR.; URINE TEST STRIPS

Catalog Number 11896954176

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter's product was requested for investigation.One test strip box package was returned for investigation.The box did not contain a test strip vial.The package showed no damages.The retention material of test strip lot 424574 was visually checked.The retention material showed no discolorations.The material fulfills requirements.

Event Description

The initial reporter stated they received a false positive nitrite result for one patient sample tested with combur 5 test strips.With the first test strip in the vial, the reporter noticed a positive discoloration in the nitrite field of the test strip.This strip was disposed of immediately.No problems were observed with other test strips in the vial.The reporter stated that other measurements performed with test strips from the vial always showed a positive nitrite result.One patient sample resulted with a positive nitrite value when tested using the test strips.When this patient sample was repeated at the doctor's office and pediatrician's office using unknown testing methods, the nitrite results were negative.The negative values were believed to be correct.

Manufacturer Narrative

The reporter's test strips were provided for investigation.The strips were checked visually and were tested with native urine and a nitrite dilution series.The results of the measurements fulfilled requirements.No false positive results were observed.

• Brand Name: COMBUR 5-TEST HC 10 STR.
• Type of Device: URINE TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9785787
• MDR Text Key: 206751056
• Report Number: 1823260-2020-00625
• Device Sequence Number: 1
• Product Code: JIL
• Combination Product (y/n): N
• PMA/PMN Number: K032437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11896954176
• Device Lot Number: 42457401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1